The biopharmaceutical industry value chain (disease discovery through post-market patient surveillance) is supported by large numbers of disparate, heterogeneous and incompatible software solutions and instrumentation. This results in significant inefficiencies, high costs and lack of control over the information residing in these many systems. In particular, solving the problems associated with management of scientific data is a critical success factor for biopharmaceutical companies in their efforts to achieve growth and revenue targets. The primary method currently employed by biopharmaceutical companies to solve the scientific data management problem has been the effort to integrate at least a portion of the systems supporting Research and Development. These data integration efforts have resulted in the creation of large (often federated) databases and/or integrated research platforms for the scientists.
Document Management Systems
Efforts at improving scientific data management include document management systems, which are increasingly addressing the content of documents, not just the management of the documents. However, as a general rule, these systems are concerned primarily with the syntactic aspects of meta-data (e.g., section 2 is placed in a specified position) and the management of the documents themselves.
Documentum currently has the largest market share for document management systems used in managing scientific data and provides the most extensive document and content management functionality. Documentum does not, however, support backward and forward traceability and does not appear to offer fine-grained entitlements, nor does it provide semantic content management.
GMPharma is a joint product of Documentum and PWC that has been developed specifically for the pharmaceutical market. It manages controlled documents and meets GMP regulatory requirements. It does not appear to support backward and forward traceability, fine-grained entitlements, or semantic content management.
PharMatrix [Opentext] is a system designed for pharmaceutical companies to coordinate and manage information. It captures, stores and disseminates information in the drug discovery phase. It does not support backward and forward traceability, fine-grained entitlements, or semantic content management. It is only available in Windows.
Astoria [Chrystal Software] is an XML based content management system. It addresses primarily the syntactic aspects of organizing a document (e.g., which parts are video, which are graphs, and the like) and does not support backward and forward traceability nor does it appear to offer fine-grained entitlements.
CyberLab [Scientific Software] is a 21 CFR 11 compliant system that manages laboratory data by cataloging, indexing, storing and keyword retrieval of everything from raw data to compliance records. It is only available in Windows. Although auditability (who did what, when and where) is supported, fine-grained traceability and fine-grained entitlements are not supported.
CoreDossier and Liquent [ESPS] are document management systems for regulated documents. They do not support semantic meta-data, entitlements or fine grained traceability.
Integrated Research Platforms
An integrated research platform is a software system that allows the scientific user (primarily in drug discovery rather than drug development) to access, manage and analyze integrated scientific data from a variety of external and internal databases. An integrated research platform is usually a solution that includes a set of products (generally proprietary).
The SRS [Lion] system provides access to a number of external databases and rudimentary managing of the resulting information. The products include a number of analytic software packages and visualization tools that are used to evaluate the data. The SRS [Lion] system does not support traceability or entitlements at any level. The use of meta-data is minimal.
Synergy (NetGenics) is a data management system that allows access to normalized integrated gene expression data from a combination of sources and which includes a set of tools to analyze the data. Synergy (NetGenics) does not support traceability, semantic meta-data or entitlements, nor is it concerned with regulatory requirements.
UNIFY, VISION and ARCHIVE [NuGenesis] make up a data management system/document repository that captures data from disparate sources, allows viewing and “cutting and pasting” of contents and automatic archiving designed to meet GLP/GMP (i.e., “Good Lab Practices”/“Good Manufacturing Practices”) guidelines. This data management system/document repository does not support fine-grained traceability, entitlements or meta-data.
GenoMax [InforMax] is a data mining platform that integrates results of genomic data analysis. It supports processing of massive amounts of disparate data types. It does not appear to support meta-data, entitlements or traceability.
Nouveau Alliance® [Nouveau Systems]is an enterprise collaborative information and process management platform targeted at the needs of R&D organizations which enables solutions that support automated capture and management of both information and process, and extended collaboration across the R&D organization.
Knowledge Management Systems/Decision Support Systems
Knowledge Management Systems/Decision Support Systems strengthen some kind of choice process. In the pharmaceutical industry, these systems are primarily simulation software systems targeting very precise areas (e.g., modeling of organic compounds). The present invention may provide services to these kinds of systems.
Insight II [MSI] provides a range of simulation and modeling systems that target molecular modeling. It does not appear to support meta-data, entitlements or traceability.
MineSet [SGI] provides data visualization in a 3D format and the ability to subject the data to “what if” analyses.
PhysioLab [Entelos] predicts the results of experimental studies and does not appear to support meta-data, entitlements or traceability.
TrialSimulator[Pharsight] optimizes, simulates and analyses clinical trial design. It does not appear to support meta-data, entitlements or traceability.
Workflow Systems
Workflow systems manage business processes. These systems define the flow of work and data, guarantee the consistency of procedures, and track and measure various metrics associated with processes.
FileNET [Panagon] emphasizes the information flow and the integration of structured and unstructured data. FileNET does not support entitlement, traceability or the use of meta-data.
MQSeries Workflow [IBM] appears to be strictly workflow control oriented and does not support content management, entitlements, meta-data or traceability.
Integration Manager [Tibco] automates and manages standard sequences of events that occur in a business. It does not appear to support content management, meta-data, traceability or entitlement.
W4 [W4] states that it is the gateway to the fully integrated value chain through its support of the virtual organization. W4 positions itself as a production, administrative and collaborative workflow product. W4 does not support meta-data, traceability or entitlements.